Une nouvelle ère pour la recherche clinique en Europe : le règlement européen n° 536/2014 relatif aux essais cliniques de médicaments à usage humain, analyse comparative et prospective

Abstract : The supervision of clinical trials is part of the drug development loop. It’s then expected that the regulation of clinical trials will define the different types of trials and will guide the Promoters in their efforts without hindering innovation. However, it has been observed that, at the same time that laws are evolving to protect patients more and to keep pace with changing practices, there are obstacles to certain types of research and limiting innovation. The administrative procedures are cumbersome and uncomfortable for the Promoters. Within the European Union, changes in the regulation of clinical trials of medicinal products were required to simplify the authorization application procedures and harmonize the evaluation of clinical trials between Member States. In order to facilitate the conduct of multinational clinical trials, harmonize practices between Member States and promote the attractiveness of the European Union, Regulation No. 536/2014 was adopted on April 16, 2014. It will repeal Directive 2001/20/EC when it comes into force. In addition, as the public gradually loses confidence in the pharmaceutical industry, transparency has become an important topic. The regulation is also intended to increase the transparency of trials and clinical data.
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Master Thesis
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Edlyne Pamphile. Une nouvelle ère pour la recherche clinique en Europe : le règlement européen n° 536/2014 relatif aux essais cliniques de médicaments à usage humain, analyse comparative et prospective. Sciences pharmaceutiques. 2018. ⟨dumas-02021125⟩

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